HS-IT101 / Sino-Cell Biomed - LARVOL DELTA

Recent Advances in Tumor-Infiltrating Lymphocyte Therapy for Melanoma. (PubMed, Curr Treat Options Oncol) - "We then review current clinical evidence for conventional TIL products, including lifileucel, TM001, LM103, HS-IT101, and GC101, highlighting their efficacy and safety profiles...In addition, advances in genetically engineered TILs, such as OBX-115, KSQ-001EX, and IOV-4001, are reviewed...Challenges and future directions of TIL therapy in melanoma are also discussed. Overall, TIL therapy constitutes a rapidly evolving and clinically potent treatment modality for melanoma."

Biomarker • IO biomarker • Journal • Review • Tumor-infiltrating lymphocyte • Genetic Disorders • Melanoma • Oncology • Skin Cancer • Solid Tumor • IL2

A Clinical Study of HS-IT101 Injection in Patients With Advanced Non-Small Cell Lung Cancer (clinicaltrials.gov) - P1 | N=12 | Not yet recruiting | Sponsor: Qingdao Sino-Cell Biomedicine Co., Ltd.

New P1 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Clinical Study of HS-IT101 Injection in the Treatment of Advanced Renal Cancer (clinicaltrials.gov) - P1 | N=15 | Not yet recruiting | Sponsor: Qingdao Sino-Cell Biomedicine Co., Ltd.

New P1 trial • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Kidney Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Fast-manufactured, low IL-2-dependent FAST-TIL for the treatment of advanced melanoma in asian patients: Median 6-month follow-up data from a phase I clinical trial (AACR 2026) - P1 | "Lymphodepletion regimens included LD-NMA conditioning (n=2: cyclophosphamide 300 mg/m² qd and fludarabine 30 mg/m² qd on Days -5 to -3) and MD-NMA conditioning (n=10: cyclophosphamide 750 mg/m² qd on Days -4 to -2, and fludarabine 30 mg/m² qd on Days -4 to -1). FAST-TIL (HS-IT101) demonstrates a favorable safety profile, promising antitumor activity, and durable clinical responses in patients with advanced melanoma. These findings support further evaluation in larger, controlled studies to confirm its therapeutic potential and establish its role in advanced melanoma treatment."

Clinical • Metastases • P1 data • Melanoma • Oncology • Solid Tumor • IL2

FAST TIL: A more effective cell therapy product with great potential for the treatment of solid tumors (AACR 2025) - P1 | "HS-IT101 has excellent quality characteristics, with the proportion of CD3+ cells > 80% and the proportion of stem cells (CD39-CD69-) > 20%. Currently, the phase I clinical trial has started for HS-IT101 (NCT06342336) since Jan 2024."

Breast Cancer • Gastrointestinal Cancer • Gynecologic Cancers • Head and Neck Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • CD69 • ENTPD1

HS-IT101 Injection Versus Chemotherapy in the Treatment of Advanced Melanoma (clinicaltrials.gov) - P2 | N=90 | Not yet recruiting | Sponsor: Qingdao Sino-Cell Biomedicine Co., Ltd.

New P2 trial • Eye Cancer • Oncology • Solid Tumor • Uveal Melanoma

Novel tumor-infiltrating lymphocytes therapy in solid tumors: latest updates from 2025 ASCO annual meeting. (PubMed, Exp Hematol Oncol) - "Notably, innovative TIL-based monotherapies and combination regimens have provided durable clinical responses and survival benefits for patients with various solid tumors. This article summarizes recent advances in TIL therapy for solid tumors presented at the 2025 ASCO Annual Meeting, highlighting monotherapies such as Lifileucel, LM103, OBX-115, GT101, GT300, GT201, and HS-IT101, as well as combination strategies with the oncolytic adenovirus TILT-123 or pembrolizumab."

Journal • Tumor-infiltrating lymphocyte • Melanoma • Oncology • Solid Tumor

A phase I clinical trial of autologous tumor-infiltrating lymphocytes FAST-TIL (HS-IT101) with low-dose IL-2 for the treatment of advanced solid tumors: Subgroup analysis of melanoma (ESMO 2025) - P1 | "2 pts received low-dose non-myeloablative conditioning(LD-NMA) (Day -5 to -3: Cyclophosphamide (Cy) 300 mg/m 2 qd; Fludarabine (Flu) 30 mg/m 2 qd), and 6 pts received middle-dose non-myeloablative conditioning(MD-NMA) (Day -4 to -2: Cy: 750 mg/m 2 , qd; Day -4 to -1: Flu: 30 mg/m 2 , qd). TCR clonal analysis showed that clones of TIL infusion product persisted long-term in the peripheral blood. Conclusions HS-IT101 injection demonstrated a favorable safety profile and promising efficacy in patients with advanced cutaneous and non-cutaneous melanoma."

Clinical • Metastases • P1 data • Tumor-infiltrating lymphocyte • Cutaneous Melanoma • Melanoma • Mucosal Melanoma • Oncology • Solid Tumor

HS-IT101 Injection in the Treatment of Advanced Melanoma (clinicaltrials.gov) - P1 | N=10 | Enrolling by invitation | Sponsor: Qingdao Sino-Cell Biomedicine Co., Ltd. | Not yet recruiting ➔ Enrolling by invitation

Enrollment open • Melanoma • Oncology • Solid Tumor

HS-IT101 Injection for Advanced NSCLC (clinicaltrials.gov) - P1 | N=12 | Not yet recruiting | Sponsor: Qingdao Sino-Cell Biomedicine Co., Ltd.

New P1 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Autologous tumor-infiltrating lymphocytes (HS-IT101) with low-dose lymphodepletion and IL-2 infusion for the treatment of advanced solid tumors: A phase I clinical trial. (ASCO 2025) - P, P1 | "Before HS-IT101 infusion, subjects will receive lymphodepletion chemotherapy consisting of cyclophosphamide (Cy) and fludarabine (Flu) for 3 - 4 days (Cy: 900/2250mg/m2 & Flu: 90/120mg/m2). The secondary endpoints include the objective response rate (ORR), disease control rate (DCR), time to response (TTR), duration of response (DOR), progression-free survival (PFS), overall survival (OS) in efficacy evaluation, and changes in relevant pharmacokinetic (PK) indicators. The exploratory endpoint is the change in pharmacodynamic (PD) indicators."

Clinical • Metastases • P1 data • Tumor-infiltrating lymphocyte • Melanoma • Oncology • Solid Tumor • IL2

HS-IT101 Injection in the Treatment of Advanced Melanoma (clinicaltrials.gov) - P1 | N=10 | Not yet recruiting | Sponsor: Qingdao Sino-Cell Biomedicine Co., Ltd.

New P1 trial • Melanoma • Oncology • Solid Tumor

HS-IT101 Injection in the Treatment of Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=44 | Recruiting | Sponsor: Qingdao Sino-Cell Biomedicine Co., Ltd.

New P1 trial • Oncology • Solid Tumor

Study on the Safety and Efficacy of Autogenous Tumor Infiltrates Lymphocytes for the Treatment of Advanced Solid Tumor (clinicaltrials.gov) - P1 | N=8 | Not yet recruiting | Sponsor: The Affiliated Hospital of Qingdao University

New P1 trial • Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Study on the Safety and Efficacy of Autogenous Tumor Infiltrates Lymphocytes for the Treatment of Advanced Breast Cancer (clinicaltrials.gov) - P1 | N=10 | Not yet recruiting | Sponsor: The Affiliated Hospital of Qingdao University

New P1 trial • Breast Cancer • Oncology • Solid Tumor